UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039706 |
|---|---|
| Receipt number | R000043895 |
| Scientific Title | Recording communication data of autism spectrum disorder and schizophrenia |
| Date of disclosure of the study information | 2020/03/05 |
| Last modified on | 2020/03/05 09:28:53 |
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Basic information
Public title
Recording communication data of autism spectrum disorder and schizophrenia
Acronym
Recording communication data of autism spectrum disorder and schizophrenia
Scientific Title
Recording communication data of autism spectrum disorder and schizophrenia
Scientific Title:Acronym
Recording communication data of autism spectrum disorder and schizophrenia
Region
| Japan | Europe |
Condition
Condition
autism spectrum disorder and schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Social skills are the ability to manage verbal and non-verbal behavior during a conversation. People who have difficulty in interacting with others struggle to properly manage their social behavior and interpret them. Social Skills Training is a well-founded method developed to train social interaction. In this study, we will collect data on how the subject and the trainer are conducting individual SST. Analyzing the verbal and non-verbal social skills of the subject and trainer from the recorded data of autism spectrum disorder and schizophrenia. The purpose of this study is to develop a system that can train social skills using virtual agents.
Basic objectives2
Others
Basic objectives -Others
Evaluate verbal response dialogue patterns, non-verbal timing, intentions, phonemes, facial expressions, gestures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verbal response dialogue pattern, non-verbal timing, intention, phoneme, facial expression, gesture
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Autism spectrum disease between 6 and under 16
Autism spectrum disorder and schizophrenia between 20 and under 50
Key exclusion criteria
intellectual disabilities, drug and alcohol abuse, personality disorders, or brain disorder
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Matsuda |
Organization
Nara Medical University School of Medicine
Division name
department of Psychiatry
Zip code
6348522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
yasumatsuda319@hotmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Matsuda |
Organization
Nara Medical University School of Medicine
Division name
department of Psychiatry
Zip code
6348522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
yasumatsuda319@hotmail.com
Sponsor or person
Institute
Nara Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Heartland Shigi
Nara Institute of Science and Technology
Centre national de la recherche scientifique
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University School of Medicine
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
smuraka@naramed-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to build a computer dialogue system that reflects SST.
Management information
Registered date
| 2020 | Year | 03 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043895
